Friday, July 22, 2011

Yesterday, I received a call from a friend who works in an interactive ad agency. He/she was eager to point out that hackers gained access to Pfizer's Facebook by discovering an administrative password based upon information that Paul Dyer, the "guy in charge of this [Pfizer's] Facebook" (according to the hackers) placed on his LinkedIn page (here).

Dyer is employed by WeissComm Partners (WCG), a PR agency that Pfizer employs to manage at least some if not all of its social media campaigns, including the corporate Facebook page. Dyer oversees the WCG social media team in North America.

My anonymous informant made some very disparaging remarks about WGC in general, and Dyer in particular. Dyer, said my informant, is a twenty-something with experience only in the packaged goods industry and has little knowledge of the pharma industry -- Dyer's previous clients (at another agency) included Coors Light, New Balance, Hansen's Natural Soda, and PURE Bar.

My informant dissed WGC, claiming they have no knowledge of the pharma industry and should not be employed by pharma to do social media.

It's not the first time that a PR agency was dissed by one of my friends who specialize in developing interactive communications and marketing programs for the pharmaceutical industry.

"Now I am not a big fan of Edelman. They are a 'legend in their own mind' and have made way too many mistakes for my money. What I do have a problem with is THE LARGEST INDEPENDENT PR FIRM IN THE WORLD just announced in the Chicago Tribune that the people who are supposed to be setting social media strategy in conjunction with communication strategy for their clients HAVE NO IDEA WHAT THEY’RE DOING!"

Myer cited this SpinSucks blog post: "Edelman Admits They Don't Know Social Media," which noted that Edelman has "what they call their 'Rotnem' program (which is mentor spelled backwards – in case you missed that) where 95 percent of their senior executives are mentored by Gen Y."

It may have been no coincidence, therefore, that Edelman recently hired Shwen Gwee -- who may be Gen X, not Y -- as VP of Digital Health. Shwen was the former Lead for Digital Strategy and Social Media (Marketing) at Vertex Pharmaceuticals. He will have his work cut out for him at Edelman.

BTW, Myer also has criticized Gwee, giving him the honor of "Most overrated industry person" (see here), claiming he doesn't deserve all the social media accolades laid upon him despite never having developed a social media campaign for a marketed drug. But just before Shwen left Vertex, he did develop a disease awareness SM campaign (BetterToKnowC.com and the HepC.TV YouTube channel).

This morning, I asked this question during the #hcsmeu chat: "PR vs Interactive agencies -- who's best for developing HC social media campaigns?" and got some interesting responses, especially from current and former pharma people.

Gary Monk (@GaryMonk), UK Managing Director at Across (a management consultancy and marketing management group), said: "I generally find Pharma #PR agencies utter crap when it comes to socmed. Better trust it to a gorilla in a wetsuit," which I found interesting, coming from a former brand manager and e-Business exec at Johnson and Johnson (Janssen division).

Monk could be biased now that works for an outside marketing company that competes with PR agencies. But a current insider, @DanBax76, who works in sales at BMS, "massively" agreed that "PR agencies are indeed more in the promo sphere, Pharma should move from promo to support."

At Pfizer, it seems pretty certain that Corporate Communications (ie, PR) is in charge of all its social media campaigns. Pfizer's head of Corp Communs, Ray Kerins, has done a lot to build the company's massive social media presence, which is ALL geared toward PUSHING messages out like a good PR machine. It's no surprise, therefore, that they would hire a PR agency like WCG. But other pharma companies are also turning to PR agencies to handle their social media campaigns, even campaigns that are more marketing focused.

My informant tells me that this is changing. As more and more social media faux pas are exposed and it is discovered that incompetent PR agencies are at fault, I expect change will happen -- more brand managers inside pharma will engage interactive marketing agencies to get the social media crumbs.

If you are a YOUNG internal pharma marketing employee with good knowledge and experience in social media, but getting nowhere in your job (listen up Pfizer people), NOW is a great time to jump ship and join an outside agency. The BIG question is: Should you join a PR agency or an innovative marketing agency?

BTW, if you opt to work for a PR agency, Gary Monk recommends Aurora (@Aurorahealthpr).

Thursday, July 21, 2011

By now, you've probably heard that Pfizer's US corporate Facebook page was "hacked" by some "Kiddies" (see "Pfizer, If You Are So Smart, How Come You Were Hacked By 'Kiddies'?"). For several hours, the page was reconfigured to display messages and images from the hackers, including "**ATTENTION** Pfizer must be stopped. They're corrupt and the damage they create is senseless. Carelessness! Putting a scare on these blokes who deserve one...".

Pfizer's FB page is now restored to its original state of corporate banality (see here). A message from Pfizer on the wall states:

"As you might have noticed, our Page was compromised last night. We have been working with Facebook to understand what happened so we can guard against it in the future. Thank you for your patience while our page has been down, and we are pleased to be sharing our news with you once more."

Several interactive agency experts who no doubt have Pfizer as a client are trying to focus the blame on Facebook. Bruce Grant, senior VP, business strategy, at Digitas Health, is on the record, quoted in MedAd Blog (see "Lessons from Pfizer Facebook hack").

According to MedAd, Grant "points out that the The Script Kiddies [the hackers] did not have a reasoned grievance against Pfizer [huh? see above], but were just repeating things they had found in the media. Pfizer was a 'villain of opportunity,' he says, and the hack was not something that Pfizer could have prevented, since the security issues were all on Facebook’s end."

Some biased observers (ie, consultants who currently work for Pfizer or may wish to work for Pfizer in the future) are reluctant to blame Pfizer and tend to shift the blame to Facebook. As I mentioned in yesterday's post, I believe Pfizer is to blame, not Facebook. As the hackers themselves said, it was easy for them to guess Pfizer's Facebook password.

What are the lessons should Pfizer and other pharma companies learn from this?

Grant suggests that when using social media, pharma companies must "control the conversation." He said: "Our advice is you don’t have a choice as to whether you have a page – your choice is whether you want to maintain appropriate control over the conversation."

I'm all in favor of having control over the conversation, but what exactly does that mean? It probably means different things to different pharma companies, which should have explicit policies in place defining what they mean by "appropriate" comments from users and what "controls" they have in place. To moderate or not to moderate, that is the question. For more on that, see "Moderation of Pharma Social Media Discussions" and links therein.

But, what are some USEFUL lessons Pfizer and other pharma companies should learn from this?

I had an interesting discussion relating to this during last night's #socpharm Twitter chat session (find the transcript here).

LESSON #1: Obviously, this first lesson is to IMPROVE your security measures. Contrary to the opinions expressed by observers such as Grant, Pfizer's security problems had nothing specifically to do with Facebook or social media. Pfizer used a WEAK password. The hackers said as much: "Hint for next time: protect the company with a LITTLE better security. One Google search and I'm in." I only hope that Pfizer uses robust passwords to gain access to its clinical trial data!

LESSON #2: Don't have technically naive people, such as corporate communications people, in charge of your social media campaigns. Pfizer even claims it has no FTEs devoted to social media (see my interview with Pixels & Pills' Sarah McLellan, here). This is a BIG mistake. When Pfizer first started its @pfizer_news twitter account, it was so unprofessional that many people thought it was a fake account. Because no one was monitoring Twitter full time for them, the conversation on Twitter proceeded without them as Ray Kerins, Pfizer's head of corporate communications, was in court fighting a traffic ticket!

BTW, Pfizer employs WeissComm Partners (WG) to manage its social media campaigns, including its Facebook page. In fact, the hackers identify Paul Dyer, who oversees the WCG social media team in North America, as the "guy in charge of this Facebook." Word is the hackers found hints to Pfizer's FB password in Dyer's LinkedIn profile (here). There, you will find that Dyer is a "Soccer player for life." Perhaps the secret password was "soccer"? Dyer's previous clients (at another agency) included Coors Light, New Balance, Hansen's Natural Soda, and PURE Bar.

LESSON #3: Don't outsource your social media projects to agencies that are even less technically savvy than you are. Take the case of Edelman creating a Facebook page for AstraZeneca (see "AstraZeneca Hosts 'Take on Depression' Facebook Discussion - Seroquel Lurks Behind the Scenes"). I was able to use Google Earth, WHOIS, etc. to discover personal information about the consultant hired by Edelman (hired by AZ) to program the discussion app on that page. If I were a hacker, the next step would have been to try and guess his password. Instead, I wrote about it and informed him of his security lapses. As a result, AstraZeneca was able to fix the problem before it became a problem.

LESSON #4: Don't blame others for your mistakes. We all are witnessing Ruppert Murdock blame his "trusted" underlings for the phone-hacking scandal in England. Similarly, we are hearing industry consultants blame Facebook for Pfizer's hack. The blame is even being extended to social media in general. @SpitzStrategy (VP, Digital Strategy at Ignite Health), for example, said "#pharma has to get used to things "going wrong" wtih SM -- that's its nature -- controlled chaos like all human communication" during last night's #scopharm chat (see here). This sends a message to other pharma companies that "shit happens" when you get involved with social media and it's OUT OF YOUR CONTROL. To which I say BULLSHIT! That is NOT the proper message to be sending to pharma. Own up to your mistakes and fix them. More importantly, don't tell us that you are working with Facebook to discover what happened and then share unspecific "lessons learned" with others.

To properly learn from these social media faux pas, pharma companies must first correctly assign blame. Let's see who Pfizer blames.

Wednesday, July 20, 2011

I read with interest the Pharmalot story about Pfizer's Facebook page being hacked by a "Kiddie" group (see "Pfizer Facebook Page Is Hacked By Script Kiddies"). I had tweeted about this and quoted the hackers who claimed that "[Pfizer's] security was laughable" (see here).

Here's what the Pfizer's FB Wall looked like when it was hacked and before it was taken down:

Pfizer has a penchant for claiming it is a leader in this and in that. But it always seems to be caught in a lie. For example, Pfizer claims that it is a leader in social media, but actually has launched very few social media applications and campaigns. It claims to have an advanced social media "playbook" that it has talked about for months but refuses to show us the "meat" (see "Pfizer, Show Us Your Social Media 'Playbook'"). When Pfizer started up it's Twitter account, it was so unprofessional, many of us thought it was not an official Pfizer account (see "Pfizer's Social Media Strategy: Piss Off John Mack, Get Hundreds of New Followers!").

Pfizer has also claimed to be a leader in security (see this post for a photo of Pfizer's past CEO, Jeff Kindler, in Pfizer's "global security bunker at company headquarters"), but if you search Google for "Pfizer security," most of the results are about breaches in Pfizer's security (see, for example, "Zombie Pfizer Computers Spew Viagra Spam").

My friend Bruce Grant was quoted in the Pharmalot story defending Pfizer: "the hack was not something that Pfizer could have prevented, since the security issues were all on Facebook’s end."

I find that hard to believe. If true, then why haven't we seen lots more corporate Facebook pages hacked? Surely, hackers would have had a field day with BP's Facebook page during the Gulf oil spill. I am assuming BP had a Facebook page at the time. Regardless, why did the "Kiddies" stop with Pfizer's FB Page, which was a pathetic social media attempt in the first place?

According to Pharmalot, Pfizer has "contacted Facebook to ask how it could have happened and plans to share what it learns with other companies [my emphasis]."

Ha Ha! I'll be making snow balls in hell before I see Pfizer sharing information that will make it look like a social media dummy. It won't even share information that will make it look smart (ie, the SM "playbook").

“The good news is that no confidential information related to individuals or the company were breached," said a Pfizer spokesperson, "but I need to make it very clear that we are committed to using social media channels to communicate and we’ll take this as a learning experience."

My opinion is that Pfizer still has a lot to learn about social media and security.

While one arm of the FDA -- the Division of Drug Marketing, Advertising, and Communications (DDMAC), the arm responsible for regulating drug promotion -- is dragging its feet issuing guidance for social media promotion (first promised for 2010, now completely off the 2011 guidance calendar; see "FDA Drops Social Media from Its 2011 Guidance Agenda"), two other arms -- the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER); responsible for regulating medical devices -- has issued guidance for mobile medical applications (see "FDA outlines oversight of mobile medical applications" where you can download the guidance document).

The guidance focuses only on a select group of applications and goes out of its way to assure the public that the FDA "will not regulate the sale or general consumer use of smartphones or tablets."

As you know, there are probably thousands of consumer-focused health apps available for smartphones. The guidance carves most of these out of its regulatory bailiwick. According to the guidance, the following represents mobile apps that FDA does NOT consider to be mobile medical apps for purposes of the guidance:

"Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition [my emphasis]. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness."

I highlighted the wording that determines whether or not FDA might consider health apps subject to being regulated as medical devices: "not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition."

The guidance defines what would make an app a mobile medical app subject to regulation as:

"When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device."

"One example," says the FDA, "is a light emitting diode (LED) included on a mobile platform with a mobile app to make that LED operate. If the manufacturer intends the system to illuminate objects generally (i.e., without a specific device intended use), neither the mobile app nor the mobile platform would be considered medical devices. If, however, through marketing and distribution, the mobile app is promoted by the manufacturer for use as a light source to examine patients, then the mobile app would meet the definition of a device. (In this case, the intended use of the light source would be similar to a conventional device such as an ophthalmoscope.)"

Are there any pharma developed and promoted mobile apps that fit this definition and thereby SHOULD be regulated as a medical mobile app?

One of the questions I had about Janssen's Psoriasis app concerned the accuracy of the formula used to calculate PASI ("Psoriasis Area and Severity Index"), which is a tool for the measurement of severity of psoriasis. The app is intended for physicians to use in diagnosing their patients. Suppose there was a "bug" in the program that calculated the PASI score? It seems that such software needs to be regulated as a medical device by the FDA.

In fact, I notice that there is an update available for Janssen's Psoriasis app. It was issued on 31 May 2011, about a month and a half after I blogged about the app. The note relating to the update merely states "bug fix." Could there have been a "bug" -- ie, ERROR -- in the formula used?

I updated my iPhone version of Janssen's Psoriasis app, but I do not notice any difference in the app nor the instructions that come with it. The "bug fix," therefore, could actually involve the software that calculates PASI.

Regardless of whether such pharma apps may be regulated by FDA as medical devices, I strongly believe that developers of health-related apps should explain in detail what "bugs" were fixed so that users have an idea of how the "bug" may have affected them. Shame on Janssen for not being more transparent in this regard!

[Like all good "leakers," my anonymous source had a motive for leaking this document to me: "I hope the info is helpful to make SM a more acceptable form of employee/customer expression and that large companies shrug off the fear that is currently associated around this platform." I am not sure this document will help ease those fears or substantiate them. See my analysis below.]

[NOTE: This document does NOT include some sections that were described by Kate Bird, Pfizer’s director of digital communications strategy, in her BlogWell presentation; ie, samples and “watch-outs,” links to all Pfizer channels, and examples of best and “next practices.” Bird described the Playbook as being "supplemental" to a longer, more formal social media policy. The document I have may actually be this "formal social media policy" rather than the playbook itself. Regardless, it offers some interesting insights into how Pfizer intends to implement social media programs.]

The first section mentioned above includes this:

"Pfizer-Sponsored external Social Media relating to prescription pharmaceutical products must not permit open fields allowing for real-time publication of user comments or posts [my emphasis]. This prohibition applies to Social Media discussing Pfizer prescription pharmaceutical products as well as Social Media that discusses only disease states and not specific prescription products."

Although the document states that "the hallmarks of all Social Media are user-generated content and interaction," Pfizer does not allow Pfizer-Sponsored Social Media projects to use the tools necessary for true interaction... UNLESS moderation can be employed. The document further states:

"Open fields on Pfizer-Sponsored external Social Media relating to prescription pharmaceutical products or disease states may be enabled for moderated comments or posts. If any open fields are enabled, in addition to being screened for adverse events, comments or posts must be moderated and pre-screened prior to publication [my emphasis]."

Any Social Media activity that discusses a Pfizer product, including pipeline products, requires prior approval from the applicable Product Review Committee, Copy Clearance Committee, or comparable review body or process, and must be submitted to regulatory authorities as required by local laws and regulations. For example, in the United States, posts related to Pfizer prescription drugs or sponsored by a Pfizer prescription drug brand team must be approved in accordance with Pfizer Process Governing Review and Approval of United States Product Team Advertising & Promotional Material, Reg. 08-01, and submitted to DDMAC under Form FDA-2253.

[No revelations in the above.]

Social Media relating to Pfizer prescription pharmaceutical products on any external Social Media:

a) must clearly disclose that the communication is sponsored by Pfizer;

b) must be fully consistent with the approved product labeling and with all applicable Pfizer policies;

c) must give a fair and balanced presentation of the benefits and risks; and

d) should appear only in appropriate media which allow for:

• inclusion of essential information such as the established name and indication as well as
the important safety information for the product;
• a link to the complete prescribing information; and
• a balanced presentation of safety and effectiveness information with comparable
prominence and readability.

Any medium that does not allow for this information to be presented may not be used for Pfizer-sponsored product discussions. Any exceptions to this prohibition must be approved by the applicable Business Unit Counsel and Regulatory Law.

[I highlighted the above in bold because this is important. It means that Pfizer prohibits branded tweets. It does, however, leave room for exceptions.]

Any team considering any Social Media activities discussing products or pipeline products must consult with their Business Unit Counsel, Regulatory Law, and the Global Privacy Office prior to engaging in such activities.

Thursday, July 14, 2011

Yesterday, I caught an early New Jersey Transit train to Manhattan to attend BDI's Social Communications & Healthcare 2011 Case Studies & Roundtables conference. I also moderated two roundtable discussions on Connecting with Healthcare Professionals.

After the conference, I attended a Tweetup organized by Shwen Ghee (@shwen) at the Birreria (@birreria) rooftop beer garden. Unfortunately, they didn't let Shwen up -- something to do with "regulations."

Anyway, I enjoyed a couple of beers with Xavier Petit (@xpetit; Shire), Marc Monseau (@MDMonseau; formerly of J&J), Robert Halper (@JNJVideo ; currently the YouTube guy at J&J), I M Wolfman (@imwolfman), and Mark Bard (@digitalhealthco; formerly of Manhattan Research, now at Digital Health Coalition).

Back to the BDI conference. A few presentations were of interest to me and I mentioned them in an on-site interview with Sarah McLellan -- the Aussie that Ate the Big Apple. See that that interview embedded below. If you haven't been interviewed by Sarah, you're missing a great treat!

As in the past, Ray Kerins (@raykerins), Vice President of Worldwide Communications at Pfizer, made the Keynote presentation, in which he mentioned Pfizer's "groundbreaking internal Social Media Playbook" that we've all been hearing about since last December or January. At that time, Kate Bird (@katebird; Digital Communications Professional for Pfizer), talked about the playbook at a BlogWell conference (see here). Bird explained what is in the Pfizer social playbook: definitions, resource repository, best practices specific to each channel, templates, samples and “watch-outs,” links to all Pfizer channels, and examples of best and “next practices.”

I also hear that the playbook includes this flowchart (from the Canadian branch of Pfizer), which only a process wonk would find useful:

I, of course, want to know if I can get a copy of this "groundbreaking" playbook. So I asked Kerins if there is anything in the playbook that can be made public or if I could get a copy of it. Kerins said: "NO!" and then he backpedaled a bit:

"The playbook and social media policy are constantly evolving. We thought we had it finished last December, and then we realized we didn't and we went back to update it. So, it's constantly moving. While I don't want to say it's proprietary, I also don't want to make too big of a deal about it because we call it common sense."

Then he trailed off about people helping people and said "you're actually seeing it action."

Of course, I am not satisfied with that answer and I don't see a lot of action in social media as far as Pfizer is concerned. Yeah, it has Twitter accounts and Facebook pages in practically every country. But where's the social media "meat?" In fact, many of the social media sites attributed to Pfizer in the online Pharma Social Media Wiki (here), such as "MS Voices," "MS Champions," and "Addressing Psoriasis" are no longer available. Others, such as the "Our Hemophilia Community" Facebook page are nothing more than drug.com websites for which the playbook has long been out of date. BTW, "Our Hemophilia Community" may soon have to shut down because of Facebook's new rules that require accepting comments on walls -- something that Pfizer does not allow (I guess that's in the playbook -- ie, don't play with consumers by allowing them to post comments).

Although several people tell me they have actually seen the playbook, no-one can actually give me a copy (citing client confidentiality). Some one sent me "Corporate Policy #407," which was written in 2008 and covered "Corporate Blogging Policy." It includes many "groundbreaking" rules such as "Adhere to all Pfizer policies," "Adhere to all compliance related rules," and "Do not use discriminatory, harassing, intimidating or offensive language as defined and discussed in Corporate Policy 303, Equal Opportunity." Basically, it's telling employees how to make personal posts on blogs.

Corporate Policy #407 cannot be what Kerins was talking about! It does not have anything to do with rules and best practices for official Pfizer social media projects.

Hoping to get hold of the AUTHENTIC Pfizer Social Media Playbook (if it exists), I tweeted this message after the conference:

"To any pfizer employee... Send me a copy of pfizer's SM playbook & you get Hawaiian shirt off my back!"

All these tactics involve protecting innovative drugs first developed and brought to market by brand drug companies. When these drugs go off patent, generic drug companies can seek FDA approval to bring "equivalent" no-name, cheaper versions of the drug to market, and thus increase competition.

Another case that recently came to my attention was COLCRYS, an FDA-approved version of colchicine, which has been available as a unbranded medicine prescribed by physicians or perhaps even "over-the-counter" without a prescription for ages -- and sold cheaply. According to Wikipedia, colchicum extract was first described as a treatment for gout in De Materia Medica by Pedanius Dioscorides in the first century.

Ever since URL Pharma got FDA approval for marketing COLCRYS for treatment of gout, it has been difficult for gout sufferers to get "generic" colchicine. This may be due to FDA's and URL Pharma's coordinated effort to wage war against colchicine.

URL Pharma's War against "generic" colchicine was recently in the news when it was discovered that its attorneys sent threatening letters to doctors who were prescribing "generic" colchicine. Some doctors had advocated use of a cheaper version of the drug, whose active ingredient is colchicine. In response, URL Pharma's general counsel sent letters to several of the critics asking them to "clarify the record" and saying there were "potential risks and liability" associated with using unapproved versions (see "Pharma Company Sends Letters to Docs Who Criticized Drug Online").

Not only doctors are complaining about this, so are patients. I recently received this letter from a reader:

"I have to write this in the dark and I can’t send it to you via the internet as the FDA, the drug companies, and the US Patent Office have me under surveillance.

"This colchicine thing is just the beginning of wiping out low price and low profit generic drugs. Preparation H could be next!

"How is it that – as you can see from my CVS receipt in January, the cost for 60 colchicine pills (one month’s supply) was $27.80 - $8 paid by me and $19.80 paid by my Part D Medicare insurance. This has been the cost ballpark for the 10 years or so that I have been taking colchicine. (My copay under Part D is 20%, so I should have paid $5.56, but I have an $8.00 minimum copay).

"But then something happened, and all of a sudden, colchicine became a “new” super drug, even though it’s been around since the days of the Roman Empire. It is now called Colcrys, and you can see from my May receipt that my 20% copayment under Part D was $51.43, meaning that the full price is now $257.15. Funny thing though – the Medication Guide that comes with Colcrys says that it is colchicine. Hmmm? But I don’t need Colcrys – I’ll take the generic colchicine – sorry, there is no generic – this is a new drug with the common name colchicine and when your doctor prescribes colchicine, this is what you will get whether you like it or not – what you were taking before is not recognized by the FDA and is not allowed to be prescribed and sold.

"What? It worked just fine, and it was really cheap. Can I get it over the counter, like fish oil or flax seed with chick pea cream sauce? Wouldn’t it be OK over the counter like all those other health junk pills? No? Why not?

"Did the FDA test and fail the original colchicine for some reason? Did the patent office actually issue a patent to AR Scientific for colchicine in direct conflict with the doctrine of prior art? (like giving me a patent for the invention of the wheel – there is no patent for wheels just like there was no patent for colchicine, so I think I’ll apply for a wheel patent and talk to General Motors about royalties.)

"What say you and your friends who monitor the drug industry about this event? Speaking of fish oil!

"From Tony – the leader of gout sufferers of America – we have enough pain as it is!"

"Unapproved colchicine products are sometimes incorrectly referred to as 'generic' colchicine. The term 'generic' drug means a drug that has been approved by FDA. In reality, there are no generic colchicine tablets."

So, there is no colchicine product that is approved by FDA as a "generic." OK, you say "generic," I say "over-the-counter." This is really semantics because the only REAL difference between OTC and branded colchicine is dosage form: FDA claims that COLCRYS is safer than colchicine primarily because it is a lower-dosage form and that "patients receiving the lower dose experienced significantly fewer adverse events compared to the higher dose:"

"FDA analyzed safety data for colchicine from adverse events reported to the Agency, the published literature, and company-sponsored pharmacokinetic and drug interaction studies. This analysis revealed cases of fatal colchicine toxicity reported in certain patients taking standard therapeutic doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. These reports suggest that drug interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine play a central role in the development of colchicine toxicity. Data submitted supporting the safety and efficacy of Colcrys in acute gout flares demonstrated that a substantially lower dose of colchicine was as effective as the higher dose traditionally used. Moreover, patients receiving the lower dose experienced significantly fewer adverse events compared to the higher dose." [See this Safety Alert.]

Tuesday, July 12, 2011

Now that I regularly use Twitter as part of my business (eg, see "Social Media Enable Your E-Mail Ad Blasts") I depend on URL shorteners to guide my @pharmaguy Twitter followers to more detailed information and messages on my blog and Web sites. Not only are URL shorteners good for conserving space in tweets, they also allow me to collect metrics such as clicks and referrers.

There are several URL shortening services I use regularly: bit.ly and Google.

Lately, I've been having problems with Google URL shortener. A few shortened URLs do not work and I get this error message:

This URL is supposed to link to the blog post "FDA, DOJ, & Google: Conspiracy Theory, Part 2", which you can find here (no URL shortener used).

My conspiracy short hairs immediately rose up upon seeing this error message (and others that referred to links to similar blog posts) and I tweeted that Google was censoring me. My Twitter friend @richmeyer posted this response: "Spoke to friend at Google you are not being censored they are having some issues."

I wish I had a friend at Google I could call, but I don't.

Google, however, makes it EXTREMELY easy for any anonymous person to report URLs as spam -- there's a "report spam button" on the bottom of the URL shortener page that links to a URL Shortener Spam Report form. Luckily, there is an option on that form for me to make a case that this URL is "Incorrectly marked as spam, please re-enable the short URL."

Meanwhile, while my report may or may not get reviewed by Google, everyone who clicks on my tweet containing the shortened URL will see that error message accusing me of being a spammer, security risk, or trafficker in illegal information! In other words, my credibility is taking a hit. Thank you Google!

UPDATE (14 July 2011): I was able to tell Google that the shortened URL in question (goo.gl/2givz) was NOT spam. To do this I had to click on the "Report Spam" link on the bottom of the URL shortener page -- oddly there was no "Dispute Spam" link. The Report Spam form had a "Incorrectly marked as spam, please re-enable the short URL." option, which I enabled.

BTW, I never received any communications from Google about the initial problem nor about the fix.

Saturday, July 09, 2011

While my son was away at school this spring, I asked him how he was doing. "OK dad," he said, "but I have this cough the last few days." I didn't have to search Google or call our physician or tweet about it to learn what may be the underlying problem. I only had to use my nose to know it was allergy season. Given my son's history, I surmised that was the root cause of his problem.

But public health officials cannot depend upon their noses to make important decisions. They need actionable real time data. How do they get it?

The Centers for Disease Control (CDC) offers the most dependable disease surveillance data. The system depends on reports from partners in state, local, and territorial health departments, public health and clinical laboratories, vital statistics offices, healthcare providers, clinics, and emergency departments. I imagine a lot of paperwork and time are involved.

Some time ago, Google decided that search trends can be used to track diseases such as influenza. It published results of a study of its data in a white paper: "Detecting influenza epidemics using search engine query data" (find it here). They found a strong correlation between search data and CDC data as shown in the chart below:

Now, researchers at the Johns Hopkins Center for Language and Speech Processing have analyzed 2 billion public tweets posted between May 2009 and October 2010 to learn if it is possible to use Twitter to track important public health trends (see "Analyzing Twitter for Public Health").

The researchers point out the differences between search and Twitter (or other social media) with regard to the intent of the user. "In web search," says Mark Dredze (one of the researchers; see a video of his presentation of results here), "the user expresses a need for information. Whereas in social media, people actually say something about themselves." In that sense, it's easier to conclude that the Twitter poster actually has the flu, whereas the searcher may or may not.

Another advantage of Twitter is that people disclose a lot of information about themselves that can add value to the public health data. This includes information about the drugs they may be taking. That information, of course, is of interest to pharmaceutical companies.

Here are the results from the Johns Hopkins study, which analyzed 1.5 million messages (out of 2 billion total collected) that referred to health matters:

Alex Butler posed a question during yesterday's #hcsmeu chat: "Have we been concentrating too much on SM as pure communication and not enough on impact of 'big data' to revolutionise health care?" This lead to a lively discussion on the value of "crowdsourcing" to somehow change healthcare. For more on that topic, see "Data Mining in the Deep, Dark Social Networks of Patients."

I can see the value of social media to do surveillance as was done in the studies mentioned above. Such surveillance certainly helps public health officials deal with certain diseases and other health issues (ie, obesity). But it doesn't change the fundamental problem of health care, which is the cost burden. To truly "revolutionise" healthcare -- IMHO -- you have to lower costs and make even rudimentary health care affordable for EVERYONE. But that's a matter for another post!

Friday, July 08, 2011

I've often wondered if FDA reads Pharma Marketing Blog. FDA has sometimes sent warning letters to pharma companies after I've blogged about violative DTC (direct-to-consumer) ads. The most famous case involved the "one-click rule" and FDA's subsequent 14 warning letters.

And Recently, my blog posts haven't been too kind to the FDA. I've even called for the resignation of Tom Abrams!

Recently, I learned that beginning July 1, 2011, the FDA may be using sophisticated monitoring tools to mine the Internet -- including "any website/blog/microblog, social media or online publication" -- that "mentions ... the FDA and special topics of interest to the FDA."

The FDA does not say why it needs to monitor sites that merely "mention" the FDA nor what "special topics" it is interested in. Could it be the agency is getting nervous about all the criticism it is getting for not being very productive in issuing social media guidance?

To do this monitoring, FDA sought the services of "small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) to provide Social Media Monitoring Services" (see "FDA Seeks Social Media Monitoring Service").

Somehow this seems creepy to me. What agency is doing the monitoring? It may be someone I know or one of my Twitter pals!

How should pharma engage in patient/physician social networks? What are some "rules of engagement" and what I call "fair social media practice principles" that can form the basis of self-regulatory SM guidelines for the pharmaceutical industry? Please respond to my survey and let me know your opinions.

Wednesday, July 06, 2011

Allergan, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, Novo, and Sanofi-Aventis filed a "citizen petition" with the FDA yesterday, urging the agency to "establish comprehensive, clear and binding regulations [my emphasis] to guide the industry" in communicating off-label drug information to physicians and payers. You can find the petition here.

Greg Kuetreman, writing about this petition in a post to Lilly's corporate blog (LillyPAD), said "we’re not asking for a change in the regulations -- just clarifications that will help us communicate in a better way." But this is not what the petition says. As I quoted above, the petition is asking for "comprehensive, clear and binding regulations."

In addition to specifically asking for regulations, rather than non-binding guidelines, there are a few other interesting points to make about this "petition" that are relevant to whether or not FDA will be able to issue social media guidance this year (or ever):

The petition asks for regulations regarding manufacturers responses to "unsolicited requests" from physicians for off-label information.

The word "Internet" and the phrase "social media" do not appear in the petition.

"Patients" and "consumers" also are NOT mentioned.

I find these points to be interesting because I recently reported that the FDA 2011 guidance calendar includes guidance for "Responding to Unsolicited Requests for Prescription Drug and Medical Device Information, Including Those Encountered on the Internet" (see "FDA Drops Social Media from Its 2011 Guidance Agenda"). Whether or not such guidance would satisfy the 7 pharma petitioners with regard to "unsolicited" requests is open to debate.

According to the FDA (see here), a citizen's petition is a way to "influence the way FDA does business... change or cancel a regulation, or to take other action." The agency receives about 200 petitions yearly. "Ultimately, FDA management decides whether to grant a petition. But first, agency staffers evaluate it, a process that may take several weeks to more than a year, depending on the issue's complexity. After FDA grants or denies the petition, the agency will notify the petitioner directly. If not satisfied, the petitioner can take the matter to court."

If the petitioners are not satisfied with how the FDA responds to the petition, they are likely to "take the matter to court" further hamstringing the FDA efforts to issue social media guidance. The number one pharma company and one of the petitioners is already on record opposing any social media guidance on first amendment grounds (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media").

Last week, at the Pharma Virtual Sales & Marketing Summit, I asked Craig Delarge, Director of Healthcare Professional Relationship Marketing at Novo Nordisk, when he thought FDA would issue social media guidance for the industry. His personal opinion was "not in the foreseeable future." That comment surprised me at the time, but now I understand why he said it.

P.S. STRANGE COINCIDENCE?
Pharma's Citizen Petition was filed on the SAME day (July 5) that DDMAC Director, Tom Abrams, said that "publishing social media guidelines for industry is the division's 'highest priority,' and that the document will be 'published as soon as it's vetted.'" Abram's comments were made at the Drug Information Association’s in Chicago (see here).

Lilly's Greg Kuetreman attempted to answer the question "Why Now?" in his blog statement, saying "Because there continues to be some confusion about what companies can - and cannot - say to health care professionals, payers, and patients about new scientific information." Considering that there's ALWAYS been this confusion, Kuetreman's statement fails to answer the question. I think the answer is that pharma anticipated imminent release SM guidelines by the FDA and wanted to delay that release by filing a Citizen Petition.

Tuesday, July 05, 2011

Harvard Medical School and Massachusetts General Hospital (MGH) have disciplined three faculty members as part of a conflict-of-interest (COI) case, which was "a prime exhibit in the debate over the federal Physician Payments Sunshine Act of 2010," reports NPR Health Blog (see "Harvard Punishes 3 Psychiatrists Over Undisclosed Industry Pay").

Drs. Joseph Biederman, Thomas Spencer and Timothy Wilens -- faculty members at Harvard Medical School -- were accused of accepting more than $4.2 million from drug companies for psychiatric research and other activities between 2000-2007 without reporting the income to Harvard, MGH or the federal government, according to NPR blog.

In their "Dear Colleagues" letter sent on Friday just before the 4th of July holiday weekend -- when not many of their colleagues would be in town -- the docs said it was an "honest mistake" (find their letter here).

The offending physicians -- one of whom (Biederman) is a "leading proponent of the off-label use of antipsychotic drugs to treat bipolar illness in children" -- claim they should have spent "more time and attention to the detailed requirements of these [COI] policies and to their underlying objectives."

It seems that a lot of doctors and medical schools make these "honest mistakes."

A commenter to the NPR blog post said "They were 'mistaken' for a seven-year period...then that's how long they should be barred from such activities." In fact, Harvard and MGH barred the three physicians from accepting payments for "all paid industry-sponsor outside activities" for only one year.

NPR said "Harvard and the MGH didn't allow much sunshine in on the outcome of its lengthy investigation of the case." Such sunshine might reveal what contributed to the 7-year "mistake" regarding compliance with the COI policies. Perhaps the policies themselves need investigation?

About the Author

Pharmaguy™ (@pharmaguy) is a "constructive critic" of the pharmaceutical industry. He is not shy about giving his opinion, which is respected by many insiders who share some of his views but who are unable to voice them on their own.